Senior Biostatistician ITALY

Description of the tasks / routine work:

• Providing statistical support to clinical studies,
• Participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• Producing randomisation schedules;
• Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs);
• Performing statistical analyses;
• Interpreting statistical results;
• Strong communication skills;

What We’re Looking For:

• Master’s degree in statistics or a related discipline. PhD strongly desired.
• 3+ years supporting clinical trial or RWE study in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• Experience in sample size calculation, protocol concept development, protocol development, SAP.
• Knowledge and implementation of advanced statistical methods.
• Good SAS programming skills.
• Knowledge of R programming a plus.
• Strong knowledge of ICH guidelines.
• Understanding & implementation of CDISC requirement for regulatory submissions is a plus.
• ADaM specifications generation and QC of datasets is a plus.
• Team player; willingness to go the extra distance to get results, meet deadlines, etc.
• Ability to be flexible when priorities change and deal with ambiguity

Language level

• Higher English level
• We will appreciate a basic Spanish knowledge or higher

Conditions:

• Contract: Permanent full-time position
• Starting date: As soon as possible
• Flexible work schedule

What We Offer

You will be part of Evidenze Group, with high international projection and opportunities to progress in Senior and Leadership positions within the company. Join a team of more than 10 biostatisticians.

We are waiting to hear from you.